embecta Announces FDA Clearance of its Disposable Patch Pump for Insulin Delivery Informed by the Unique Needs of People with Type 2 Diabetes
embecta (EMBC) has received FDA 510(k) clearance for its proprietary disposable insulin delivery system, designed for both type 1 and type 2 diabetes patients. The system features a tubeless patch pump with a 300-unit insulin reservoir, addressing the needs of type 2 diabetes patients who typically require higher daily insulin doses. This larger reservoir can meet the needs of 64% of adults with type 2 diabetes for three-day wear, compared to only 38% for a 200-unit reservoir.
The system includes a wearable, disposable patch pump and a controller with Bluetooth technology and a color touchscreen. embecta is also developing a closed-loop version with an insulin-dosing algorithm for future FDA submission. This milestone aligns with embecta's strategic priorities and vision of improving life for people with diabetes.
embecta (EMBC) ha ricevuto l'approvazione 510(k) dalla FDA per il suo sistema di distribuzione di insulina usa e getta, progettato per pazienti con diabete di tipo 1 e tipo 2. Il sistema presenta una pompa a patch senza tubi con un serbatoio per insulina da 300 unità, che risponde alle esigenze dei pazienti diabetici di tipo 2, che solitamente richiedono dosi giornaliere di insulina superiori. Questo serbatoio più grande può soddisfare le necessità del 64% degli adulti con diabete di tipo 2 per un utilizzo di tre giorni, rispetto solo al 38% per un serbatoio da 200 unità.
Il sistema include una pompa a patch indossabile e usa e getta e un controller con tecnologia Bluetooth e uno schermo touchscreen a colori. embecta sta anche sviluppando una versione a circuito chiuso con un algoritmo di dosaggio dell'insulina per un futuro invio alla FDA. Questo traguardo è in linea con le priorità strategiche di embecta e la sua visione di migliorare la vita delle persone con diabete.
embecta (EMBC) ha recibido la aprobación 510(k) de la FDA para su sistema desechable de entrega de insulina, diseñado para pacientes con diabetes tipo 1 y tipo 2. El sistema cuenta con una bomba de parche sin tubos con un reservorio de insulina de 300 unidades, que atiende las necesidades de los pacientes con diabetes tipo 2 que generalmente requieren dosis diarias más altas de insulina. Este reservorio más grande puede satisfacer las necesidades del 64% de los adultos con diabetes tipo 2 durante tres días de uso, en comparación con solo el 38% para un reservorio de 200 unidades.
El sistema incluye una bomba de parche desechable y portátil y un controlador con tecnología Bluetooth y pantalla táctil a color. embecta también está desarrollando una versión de circuito cerrado con un algoritmo de dosificación de insulina para una futura presentación a la FDA. Este hito se alinea con las prioridades estratégicas de embecta y su visión de mejorar la vida de las personas con diabetes.
엠벡타 (EMBC)는 일회용 인슐린 전달 시스템에 대해 FDA 510(k) 승인을 받았습니다. 이 시스템은 제1형 및 제2형 당뇨병 환자를 위해 설계되었습니다. 이 시스템은 튜브가 없는 패치 펌프와 300단위 인슐린 저장소를 특징으로 하며, 일반적으로 더 높은 일일 인슐린 용량이 필요한 제2형 당뇨병 환자의 필요를 충족합니다. 이 더 큰 저장소는 3일 동안 사용하는 데 필요한 제2형 당뇨병 성인의 64%의 필요를 충족할 수 있으며, 200단위 저장소의 경우는 38%에 불과합니다.
시스템에는 착용 가능한 일회용 패치 펌프와 블루투스 기술이 있는 컨트롤러, 컬러 터치스크린이 포함되어 있습니다. 엠벡타는 또한 향후 FDA 제출을 위한 인슐린 투여 알고리즘이 있는 폐쇄 루프 버전을 개발하고 있습니다. 이 이정표는 엠벡타의 전략적 우선 사항 및 당뇨병 환자의 삶을 개선하겠다는 비전과 일치합니다.
embecta (EMBC) a reçu l'autorisation 510(k) de la FDA pour son système de distribution d'insuline jetable, conçu pour les patients atteints de diabète de type 1 et de type 2. Le système comprend une pompe à patch sans tube avec un réservoir d'insuline de 300 unités, répondant aux besoins des patients diabétiques de type 2 qui nécessitent généralement des doses d'insuline plus élevées. Ce réservoir plus grand peut satisfaire les besoins de 64% des adultes atteints de diabète de type 2 pendant trois jours d'utilisation, contre seulement 38% pour un réservoir de 200 unités.
Le système comprend une pompe à patch jetable et portable, ainsi qu'un contrôleur doté de la technologie Bluetooth et d'un écran tactile couleur. embecta développe également une version en boucle fermée avec un algorithme de dosage de l'insuline pour une future soumission à la FDA. Cette étape est en accord avec les priorités stratégiques d'embecta et sa vision d'améliorer la vie des personnes atteintes de diabète.
embecta (EMBC) hat die FDA 510(k)-Zulassung für ihr einweg Insulinabgabesystem erhalten, das für Patienten mit Typ-1- und Typ-2-Diabetes entwickelt wurde. Das System verfügt über eine tubuslose Patchpumpe mit einem 300-Einheiten Insulinreservoir, das auf die Bedürfnisse von Typ-2-Diabetes-Patienten eingeht, die in der Regel höhere tägliche Insulindosen benötigen. Dieses größere Reservoir kann die Bedürfnisse von 64% der Erwachsenen mit Typ-2-Diabetes für eine dreitägige Anwendung erfüllen, im Vergleich zu nur 38% für ein 200-Einheiten-Reservoir.
Das System umfasst eine tragbare, einweg Patchpumpe und einen Controller mit Bluetooth-Technologie und einem Farb-Touchscreen. embecta entwickelt auch eine geschlossene Version mit einem Insulin-Dosierungsalgorithmus für eine zukünftige FDA-Einreichung. Dieser Meilenstein steht im Einklang mit den strategischen Prioritäten von embecta und der Vision, das Leben von Menschen mit Diabetes zu verbessern.
- FDA 510(k) clearance received for proprietary disposable insulin delivery system
- 300-unit insulin reservoir meets needs of 64% of adults with T2D for three-day wear
- System designed to address obstacles in adopting pump therapy for daily insulin users
- Platform serves as basis for future automated insulin delivery system
- None.
The FDA clearance of embecta's disposable patch pump marks a significant advancement in insulin delivery for Type 2 Diabetes (T2D) patients. The 300-unit insulin reservoir is a game-changer, addressing a important need for higher-capacity devices. This innovation could potentially increase pump adoption rates among T2D patients, who often require larger insulin doses.
The system's design, focusing on simplicity and user experience, may help overcome barriers to pump therapy adoption. However, the success will largely depend on pricing, insurance coverage and healthcare provider education. The planned closed-loop version could further enhance its appeal, potentially improving glycemic control and reducing the burden of diabetes management for a significant portion of the diabetes population.
embecta's entry into the insulin pump market with this FDA-cleared device presents a substantial market opportunity. With
However, embecta faces stiff competition from established players like Insulet and Tandem. Success will hinge on effective marketing, competitive pricing and building strong relationships with healthcare providers. The planned closed-loop system could be a key differentiator in the future. Investors should monitor initial adoption rates and reimbursement decisions by insurers, as these will be critical indicators of the product's market potential and embecta's revenue growth prospects.
This FDA clearance is a pivotal moment for embecta, potentially opening up a significant revenue stream. The addressable market is substantial, given the prevalence of T2D. However, investors should temper short-term expectations as market penetration and revenue ramp-up will take time.
Key financial metrics to watch include:
- Initial sales figures and adoption rates
- Gross margins on the device
- R&D expenses for the closed-loop version
- Marketing and education costs
While this news is positive, embecta's financial performance will depend on successful commercialization. The company's ability to scale production, manage costs and navigate reimbursement landscapes will be crucial. Investors should also consider potential impacts on the company's existing product lines and overall financial health.
- While 9 out of 10 people with diabetes are living with T2D, many of the automated insulin delivery solutions currently on the market were designed for people living with T1D.
- 300-unit insulin reservoir is more suitable for people with T2D who are interested in moving from multiple daily injections (MDI) to pump therapy, based on an average daily dose of 95.9 units of insulin.1
PARSIPPANY, N.J., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Embecta Corp. ("embecta") (Nasdaq: EMBC), a global diabetes care company with a 100-year legacy in insulin delivery, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary disposable insulin delivery system. Indicated for adults who require insulin to manage diabetes, including both type 1 (T1D) and type 2 (T2D), the system includes a tubeless patch pump design with a 300-unit insulin reservoir that was informed by feedback from people with T2D and their healthcare providers.
“FDA clearance of our disposable insulin delivery system has been a top strategic priority for our team since launching embecta as an independent company, and achieving this milestone through strong execution exemplifies our commitment to making life better for the growing number of people living with diabetes,” said Dev Kurdikar, CEO. “As we continue to advance toward our vision of a life unlimited by diabetes, our team has focused on developing a patch pump that could address some of the most significant obstacles to adopting pump therapy for people who use insulin daily to manage their diabetes. This platform is also serving as the basis for an automated insulin delivery system in development.”
The system includes a wearable, fully disposable patch pump that provides adjustable basal and bolus insulin for up to three days, depending on the needs of the user. The patch pump features a 300-unit insulin reservoir that accommodates people who have higher daily insulin needs, which is typically true of people with T2D. For such people, the on-market patch pumps may not hold enough insulin to meet their needs for three days.2 For example, a recent embecta-sponsored study3 showed that a 300-unit insulin reservoir would meet the needs of
In addition to the patch pump, the system comprises a locked-down controller featuring Bluetooth® wireless technology with a color touchscreen designed to create a simplified interface and user experience.
“Our research and development, medical affairs and regulatory teams identified an unmet need within the diabetes community and shepherded this project from concept to clearance with dedication and diligence,” said Dr. Colleen Riley, Chief Technology Officer. “I want to thank the embecta team for their commitment to serving people with diabetes and thank the FDA for their timely review and clearance of a system that has the potential to reduce the burden of managing diabetes for more people and significantly move innovation in this area forward.”
embecta’s patch pump development program also includes plans for a closed-loop version including an insulin-dosing algorithm in a future FDA submission.
References:
1Viral Shah, MD, et al, Insulin dosing in U.S. adults with type 2 diabetes (T2D) on multiple daily injections (MDI): A retrospective cohort study
2Ekanayake P, Edelman S. Identifying patients with type 2 diabetes who might benefit from insulin pump therapy: Literature review, clinical opportunities, potential benefits and challenges. Diabetes Obes Metab. 2023; 1‐18.
3 Eugene E. Wright, Jr., MD, et al, Evaluating Need for Larger Insulin Reservoir in Patch Pumps: Leveraging Retrospective Dose Data for US Adults with T2D on MDI, https://www.embectamedical.com/pdf/ADA-Poster-1902.pdf
4 Freckmann G, Buck S, Waldenmaier D, et al. Insulin Pump Therapy for Patients With Type 2 Diabetes Mellitus: Evidence, Current Barriers, and New Technologies. Journal of Diabetes Science and Technology. 2021;15(4):901-915.
About embecta
embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships, and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and X.
Safe Harbor Statement Regarding Forward-Looking Statements
This press release contains express or implied "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 and other securities laws. These forward-looking statements concern embecta’s current expectations regarding its future results from operations, business plans, product performance and impact, and new and anticipated product approvals and launches. These forward-looking statements are subject to various known and unknown risks, uncertainties and other factors, and you should not rely upon them except as statements of our present intentions and of embecta’s present expectations, which may or may not occur. When embecta uses words such as "believes," "expects," "anticipates," "estimates," "plans," "intends", "pursue", "will," "seek," “potentially”, “may,” or similar expressions, it is making forward-looking statements. For example, embecta is using forward-looking statements when it discusses continuing to invest in its patch pump development program, plans for a closed-loop version, future FDA submissions, and working with the FDA to seek clearance for any of the foregoing. Although embecta believes that its forward-looking statements are based on reasonable assumptions, its expected results may not be achieved, and actual results may differ materially from its expectations. In addition, important factors that could cause actual results to differ from expectations include, among others: (i) embecta’s ability to obtain clearance from the FDA of any product; (ii) its ability to market and sell such products successfully; (iii) its ability to anticipate the needs of people with diabetes; (iv) its ability to successfully complete clinical and other trials with favorable results, obtain regulatory clearance and obtain approvals for its products; (v) its ability to manufacture such products in a cost-effective manner, comply with FDA’s quality system regulations, obtain appropriate intellectual property protection for such products, gain and maintain market acceptance of such products, secure distribution channels, and obtain access, coverage and reimbursement for such products; (vi) future economic, competitive, reimbursement and regulatory conditions; (vii) litigation; (viii) financial market conditions; (ix) future business decisions made by embecta and its competitors; (x) technological innovations or changes in clinical practice adversely affecting embecta’s business; and (xi) the other risks described in embecta’s periodic reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors" in its most recent Annual Report on Form 10-K, as further updated by its Quarterly Reports on Form 10-Q it has filed or will file hereafter. Except as required by law, embecta undertakes no obligation to update any forward-looking statements appearing in this press release.
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